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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 219058 | 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | TABLET;ORAL | EQ 3MG BASE | TARO | 2025-08-06 | No | No | RX | AB |
(ANDA) 219058 | 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 盐酸多塞平 | TABLET;ORAL | EQ 6MG BASE | TARO | 2025-08-06 | No | No | RX | AB |
(ANDA) 219156 | 001 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | 二十碳五烯酸乙酯 | CAPSULE;ORAL | 1GM | XIAMEN LP PHARM CO | 2025-08-06 | No | No | RX | AB |
(ANDA) 218142 | 001 | ERIBULIN MESYLATE | ERIBULIN MESYLATE | 甲磺酸艾立布林 | SOLUTION;INTRAVENOUS | 1MG/2ML (0.5MG/ML) | XILING LAB | 2025-08-05 | No | No | RX | AP |
(ANDA) 214279 | 001 | SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | 舒更葡糖钠 | SOLUTION;INTRAVENOUS | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | FISIOPHARMA | 2025-08-05 | No | No | RX | AP |
(ANDA) 212470 | 001 | BUMETANIDE | BUMETANIDE | 布美他尼 | TABLET;ORAL | 0.5MG | JUBILANT GENERICS | 2025-08-05 | No | No | RX | AB |
(ANDA) 212470 | 003 | BUMETANIDE | BUMETANIDE | 布美他尼 | TABLET;ORAL | 2MG | JUBILANT GENERICS | 2025-08-05 | No | No | RX | AB |
(ANDA) 212470 | 002 | BUMETANIDE | BUMETANIDE | 布美他尼 | TABLET;ORAL | 1MG | JUBILANT GENERICS | 2025-08-05 | No | No | RX | AB |
(ANDA) 218888 | 001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | 盐酸多西环素 | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | ASPIRO | 2025-08-05 | No | No | RX | AP |
(ANDA) 211219 | 001 | ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 醋酸艾司利卡西平 | TABLET;ORAL | 200MG | JUBILANT GENERICS | 2025-08-04 | No | No | RX | AB |
(ANDA) 211219 | 003 | ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 醋酸艾司利卡西平 | TABLET;ORAL | 600MG | JUBILANT GENERICS | 2025-08-04 | No | No | RX | AB |
(ANDA) 219475 | 001 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | 盐酸莫西沙星 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | FDC LTD | 2025-08-04 | No | No | RX | AT1 |
(ANDA) 211219 | 002 | ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 醋酸艾司利卡西平 | TABLET;ORAL | 400MG | JUBILANT GENERICS | 2025-08-04 | No | No | RX | AB |
(ANDA) 211219 | 004 | ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 醋酸艾司利卡西平 | TABLET;ORAL | 800MG | JUBILANT GENERICS | 2025-08-04 | No | No | RX | AB |
(NDA) 218585 | 001 | VIZZ | ACECLIDINE HYDROCHLORIDE | 盐酸醋克利定 | SOLUTION/DROPS;OPHTHALMIC | EQ 1.44% BASE | LENZ THERAP | 2025-07-31 | Yes | Yes | RX | |
(ANDA) 218117 | 001 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 2.5MG | SCIEGEN PHARMS INC | 2025-07-31 | No | No | RX | AB |
(ANDA) 218117 | 004 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 20MG | SCIEGEN PHARMS INC | 2025-07-31 | No | No | RX | AB |
(ANDA) 218117 | 003 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 15MG | SCIEGEN PHARMS INC | 2025-07-31 | No | No | RX | AB |
(ANDA) 218117 | 002 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 10MG | SCIEGEN PHARMS INC | 2025-07-31 | No | No | RX | AB |
(ANDA) 219363 | 001 | METHYLENE BLUE | METHYLENE BLUE | 亚甲蓝 | SOLUTION;INTRAVENOUS | 50MG/10ML (5MG/ML) | XIROMED | 2025-07-30 | No | No | RX | AP |